The present invention relates to a sampling device for obtaining a tissue or mucus sample from the cervical os or from the upper region of the vagina (vaginal fornix) without undue contamination of the sample by vaginal fluids.
Collection of cervical material in the form of tissue and mucus has been routinely performed for many years. Such retrieved samples are then tested for malignancy by the Pap test or examined for various purposes such as the determine whether ovulation has occurred.
The probes or devices generally used to obtain such cervical samples for examination and testing have not been designed for self-use by women wishing to collect cervical specimens at home. In most instances, skilled medical personnel obtain the required sample for testing. Some recent patents disclose sampling devices designed specifically for self-use by women.
U.S. Pat. No. 3,592,186 relates to an apparatus for self-use in the collection of cervical samples for evaluation. The apparatus comprises a substantially resilient scraper having a generally irregular heart-shape telescopically engaged within a protective cover. When the apparatus is disposed substantially within the female body at the vaginal opening, the scraper is extensible and rotatable by the individual from whom the sample is to be obtained. An indexer is provided to give external indication to the operator of the relative position of the scraper when in operation.
U.S. Pat. No. 3,776,219 discloses a cervical scraper unit designed particularly for utilization by the female herself. The scraper comprises a conical polyurethane foam head cantilevered at the end of a hollow plastic tube and enveloped by a plurality of protective flexible petal-like appendages. The head is mounted to be exposed by the petals at the testing site, and to accommodate its collapse and flexion when it is rotated in situ against the entrance to the cervix. Subsequently, the petals are arranged to envelop and protect the head during withdrawal. The ability of the scraper to collapse and to flex, its resilient nature, and its conical shape, along with the protection of the sample by the petals, are all said to contribute to the efficiency and completeness of transfer of a collected sample for examination.
U.S. Pat. No. 4,131,112 provides a probe for obtaining a sample of cervical mucus which comprises a syringe-like structure characterized by an outer barrel and an inner plunger capable of producing relative peristaltic motion. The cooperating forward configurations of the outer barrel and the inner plunger defines therebetween the specimen cavity which, when it is caused to increase in volume with rearward motion of the plunger, receives a fluid specimen through the forward opening under suction and when it is caused to decrease in volume with forward motion of the plunger, ejects the fluid specimen through the forward opening under pressure.
U.S. Pat. Nos. 4,157,709 and 4,318,414 disclose probes for inserting a test element into the vaginal cavity while shielding it from intermediate vaginal contact, for positioning the test element in contact with the cervical os with the aid of a reference foot, in order to collect a specimen of cervical material and for retrieving the test element and the specimen from the vaginal cavity while shielding them from intermediate vaginal contact.
Other devices for collecting samples of cellular cervical material are disclosed in U.S. Pat. Nos. 3,640,268 and 3,664,328.